The present disclosure relates generally to controls for phototherapeutic devices useful for ultraviolet light phototherapy. Methods of making and using such controls and/or devices are also disclosed.
Phototherapy relates to the treatment of disease, such as skin conditions including psoriasis, acne, eczema, vitiligo, and mycosis fungoides, by exposure to light, especially by various concentrated light rays such as long-wave or short-wave ultraviolet light. The treatment may be alone or in combination with a sensitizer which sensitizes the skin to light.
In particular, ultraviolet light (“UV light,” radiation in the region of the electromagnetic spectrum including wavelengths from 100 to 4000 angstroms) has been used for over 30 years in a clinical setting for treating severe skin diseases, such as psoriasis and vitiligo. The treatment regimen is called phototherapy.
In a clinical setting, a physician, nurse or phototherapy technician is responsible for ensuring that a patient receives the correct treatment protocol. The protocol comprises a series of light exposure sessions including the duration of exposure for each session and the frequency of sessions (i.e, the interval between sessions).
In the 1990s, National Biological Corporation of Twinsburg, Ohio began offering a home-based phototherapy medical device that was approved by the Food and Drug Administration for sale in the United States. One concern of such a device was that unsupervised usage of the device by patients to administer ultraviolet light sessions could result in patients burning themselves. This concern was ameliorated by the provision of a prescription-controlled timing device, known as a controlled prescription timer, in phototherapy medical devices offered under the brand name PANOSOL II.
In the PANOSOL II, the controlled prescription timer was preprogrammed with a fixed number of sessions for the patient. When the fixed number of sessions was exhausted, the patient could obtain additional sessions by contacting their physician. The physician would authorize the additional sessions by providing a code number that the patient would enter into the keypad of their home phototherapy device. For additional information, see U.S. Pat. Nos. 5,604,619 and 6,345,215, the entire contents of both patents being fully incorporated herein by reference. National Biological Corporation has sold over 15,000 home phototherapy devices in the 10-year period up to 2006.
However, more people could benefit from home-based ultraviolet light phototherapy. For example, an estimated 2-3% of the population has a severe version of the skin disease psoriasis. Psoriasis is a common skin disease characterized by thickened patches of inflamed, red skin, often covered by silvery scales. The exact cause of psoriasis is not known. It affects men and women relatively equally. The underlying abnormality in psoriasis is that new skin cells are produced much faster than normal, but the rate at which cells are shed remains unchanged. Consequently, the live cells build up and form thickened patches covered with dead, flaky skin.
Phototherapy is generally considered the safest, most effective, and least expensive option for sufferers of severe psoriasis. With the US population approaching 300 million, 9 million potential patients could benefit from a home phototherapy device.
Some prescribing dermatologists have embraced the control offered by the controlled prescription timer and prescribed home phototherapy. However, a controller that provides additional control over patients' usage of the phototherapy device is beneficial.
Accordingly, there is a need for devices that provide additional control over patients' usage of a home-based phototherapy device.